The HYALEX Freestyle™ Resurfacing System Pivotal Study: A Multicenter, Single-Arm, Pivotal Study of the HYALEX Freestyle Resurfacing Implant
Hyalex Orthopaedics, Inc.
Summary
A multicenter, open-label, single-arm, pivotal study to evaluate the safety and effectiveness of the HYALEX Freestyle Resurfacing System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Freestyle Resurfacing Implant.
Eligibility
- Age range
- 22–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria (Phase 1): 1. 22-70 years. 2. Body Mass Index (BMI) ≤ 40. 3. Up to two treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial and/or lateral femoral condyle. 4. Up to 2 implants (one implant per condyle) to treat up to 2 individual symptomatic lesions with a total summative area up to 4.52cm2 / condyle. 5. Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65. 6. Ligamentously stable knee. 7. Failure of non-operative treatment (e.g., physical therapy, physician-directed at home exercise program, intra-articular injection…
Interventions
- DeviceHyalex Knee Cartilage System
Surgical implantation of the Hyalex Knee Cartilage System
Locations (4)
- Horizon Clinical ResearchLa Mesa, California
- Ochsner Sports Medicine InstituteNew Orleans, Louisiana
- Hospital for Special SurgeryNew York, New York
- Oregon Health & Science UniversityPortland, Oregon